Support to meet the maintenance needs of manufacturing specifically compliance, quality, time, and budget. This position supports a culture of continuous improvement by researching, proposing, and implementing measures to drive innovation, reduce wastes, and apply engineering principles/knowledge to continuously improve safety, technical compliance, equipment, and process reliability.
- Role that this position reports to: Sr. Manager, Maintenance Services per Value Stream
- Role/s that report to this position: None
Responsibilities:
1. Serves as the technical lead and supports the specification, installation, utilization, qualification, and improvement of equipment used for assigned manufacturing area.
• Understands the functionality and operation of the equipment.
• Responsible for the current and future design of the equipment/system.
• Accountable for keeping technology current.
• Identifies and implements best demonstrated practices (via Communities of Practice or other methods).
• Owns SOP/work instructions for operating system/equipment.
• Develops training and troubleshooting guides.
2. Ensure the technical reliability as well as the safety of production facilities in the assigned manufacturing department. Work to improve equipment reliability as measured by Operational Equipment Effectiveness (OEE).
• Evaluates and updates PMs to keep system performance optimal.
• Implements and monitors predictive maintenance of the system to prevent breakdowns of the system.
• Implements and monitors TPM to ensure the system stays in like-new condition.
3. Works collaboratively with multiple functional areas such as EHS, Quality, Process Engineering and Manufacturing.
• Ensures the system can be operated safely by the operators.
• Minimizes quality deviations and discards associated with the system.
• Maximizes efficiency/OEE, yield, output, & capacity of the system.
• Updates maintenance and calibration plans collaborating with the expert groups.
4. Providing data analysis to identify technical changes and replacement investments based on de- bottlenecking and long-term, obsolescence strategies.
• Prevents obsolesce of system parts and components that can impact safety, quality, and reliability.
• Oversees reconditioning of the equipment to restore to like-new condition.
• Performs upgrades to improve safety, operational performance, and extend operational life.
• Develops end-of-life replacement plan for the system to ensure reliable supply to our patients.
• Collaborates with local and global partners to develop asset management plan that includes capital requests.
5. Ensure equipment and processes are compliant with the government regulations. Acts as equipment
6. SME during internal or external Regulatory inspections.
7. Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
8. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
9. Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
10. Completes any other duties/responsibilities assigned by senior management.
Qualifications:
• Requires a bachelor’s degree in Mechanical, Chemical or Manufacturing Engineering.
• 4+ years of relevant experience and a BS
• 2+ years of relevant experience and a MS.
• In Lieu of a degree, a minimum of 10 years’ experience in Manufacturing Maintenance filter press field.
• Prior experience in pharmaceutical industry is preferred.
• Proficient knowledge of Good Manufacturing Practices (GMPs)
• Audit and Investigation Skills, Report Writing Skills.
• Strong verbal, technical writing and interpersonal skills are required.
• Proficiency in Microsoft Office applications.
• Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
• Collaborates
• Instills Trust
• Drives Results
• Situational Adaptability
• Communication Effectively
• Drives Engagement
The expected base salary range for this position at hiring is $75,000 - $95,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!
